Instruments and methods for adjusting separation distance of vertebral bodies with a minimally invasive spinal stabilization procedure

ABSTRACT

A spinal stabilization system may be formed in a patient. In some embodiments, a minimally invasive procedure may be used to form a spinal stabilization system in a patient. Bone fastener assemblies may be coupled to vertebrae. Each bone fastener assembly may include a bone fastener and a collar. Extenders may be coupled to the collar to allow for formation of the spinal stabilization system through a small skin incision. The extenders may allow for alignment of the collars to facilitate insertion of an elongated member in the collars. An elongated member may be positioned in the collars and a closure member may be used to secure the elongated member to the collars. An adjuster may be used in conjunction with the extenders to change a separation distance between the bone fastener assemblies.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.14/164,359, filed Jan. 27, 2014, which is a continuation of Ser. No.13/486,232, filed Jun. 1, 2012, now U.S. Pat. No. 8,636,743, issued Jan.28, 2014, which is a continuation of U.S. patent application Ser. No.12/623,204, filed Nov. 20, 2009, now U.S. Pat. No. 8,192,440, issuedJun. 5, 2012, which is a continuation of U.S. patent application Ser.No. 11/002,931, filed Dec. 2, 2004, now U.S. Pat. No. 7,811,288, issuedOct. 12, 2010, the contents of which are fully incorporated herein byreference.

BACKGROUND

Field of the Invention

The present invention generally relates to instruments and methods usedduring a spinal stabilization procedure to manipulate vertebrae. Moreparticularly, the present invention generally relates to spinal surgicalprocedures that use instruments and methods for adjusting a separationdistance between adjacent vertebrae.

Description of Related Art

Bone may be subject to degeneration caused by trauma, disease, and/oraging. Degeneration may destabilize bone and affect surroundingstructures. For example, destabilization of a spine may result inalteration of a desired spacing between adjacent vertebrae. Alterationof a desired spacing between adjacent vertebrae may subject nerves thatpass between vertebral bodies to pressure. Pressure applied to thenerves may cause pain and/or nerve damage. Maintaining the desiredspacing between vertebrae may reduce pressure applied to nerves thatpass between vertebral bodies. A spinal stabilization procedure may beused to establish and/or maintain the desired spacing between vertebraeand promote spinal stability.

Spinal stabilization may involve accessing a portion of the spinethrough soft tissue. Conventional stabilization systems may require alarge incision and/or multiple incisions in the soft tissue to provideaccess to a portion of the spine to be stabilized. Conventionalprocedures may result in trauma to the soft tissue, for example, due tomuscle stripping.

U.S. Pat. No. 6,530,929 to Justis et al. (hereinafter “Justis”), whichis incorporated by reference as if fully disclosed herein, describesminimally invasive techniques and instruments for stabilizing a bonystructure in an animal subject. Justis provides a method for using aninstrument to connect at least two bone anchors with a connectingelement. The instrument is secured to the anchors and manipulated toplace the connecting element in a position more proximate the anchors.The Justis system is a constrained system. An elongated member installedusing the Justis instruments and method must have a set curvature tofunction with the installation instruments.

U.S. Patent Publication No. U.S. 20040138662 to Landry et al.(hereinafter “Landry”), which is incorporated by reference as if fullydisclosed herein, describes a minimally invasive procedure andinstruments for stabilizing a portion of the spine. The Landry system isnot a constrained system. An elongated member installed using the Landryinstruments and method does not need to have a curvature defined by theinsertion instruments.

SUMMARY

A spinal stabilization system may be installed in a patient to stabilizea portion of a spine. A spinal stabilization system may be installedusing a minimally invasive procedure. An instrumentation kit may provideinstruments and spinal stabilization system components necessary forforming a spinal stabilization system in a patient. The instrumentationkit may include one or more adjusters. An adjuster may change aseparation distance between adjacent vertebrae. In some embodiments, theadjuster may be a compressor used to reduce a separation distancebetween vertebrae. In some embodiments, the adjuster may be a distractorused to increase a separation distance between vertebrae.

A spinal stabilization system may be used to achieve rigid pediclefixation while minimizing the amount of damage to surrounding tissue. Insome embodiments, a spinal stabilization system may be used to providestability to two or more vertebrae. A spinal stabilization system mayinclude an elongated member, two or more bone fastener assemblies,and/or a closure member.

A bone fastener assembly may include, but is not limited to, a bonefastener and a collar. A first portion of the bone fastener may coupleto a vertebra. A first portion of a collar may couple to a secondportion of the bone fastener. A second portion of the collar may coupleto an elongated member during use. In some embodiments, the bonefastener may be able to rotate relative to the collar prior to insertionof the elongated member. After the bone fastener is placed in avertebral body, the collar coupled to the bone fastener may bepositioned so that the elongated member can be placed in the collar andin at least one other collar that is coupled to another vertebral bodyby a bone fastener.

During some spinal stabilization procedures, a spinal implant or otherdevice may be inserted using an anterior approach, lateral approach orposterior approach. To stabilize the spinal implant or other device, astabilization system may be installed using a posterior approach. Insome embodiments, the spinal stabilization system may be installed usinga minimally invasive surgical procedure where the stabilization systemis installed through a small incision formed in the patient. During somesurgical procedures, movement of vertebrae closer together may bedesired to secure the position of an installed spinal implant or otherdevice and/or to promote bone growth. During some surgical procedures,movement of vertebrae farther apart may be desired to provide a desiredspacing between the vertebrae and/or to allow working room formanipulation of a device positioned between the vertebrae. An adjustermay be used with instruments used to install the spinal stabilizationsystem to change the position of vertebrae coupled together by thespinal stabilization system. The adjuster may allow a closure member tobe secured to a collar of the spinal stabilization system while adesired separation distance is maintained between the vertebrae.

A system for adjusting a distance between vertebral bodies may include afirst extender coupled to a first bone fastener assembly. The first bonefastener assembly may be secured to a first vertebral body. A closuremember may secure an elongated member to the first bone fastenerassembly to inhibit movement of the elongated member relative to thefirst bone fastener assembly. The system may include a second extendercoupled to a second bone fastener assembly that is secured to a secondvertebral body. The system may include an adjuster. A portion of theadjuster may couple to the first extender. The system may include adriver. The driver may be coupled to the adjuster and to the secondextender. A closure member coupled to the driver may be loosely threadedon the second bone fastener assembly such that the bone fastenerassembly is able to move along the elongated member. The adjuster mayrotate the driver to allow the driver to move the second extenderrelative to the elongated member to adjust the separation distancebetween the first vertebral body and the second vertebral body. In someembodiments, an axis of rotation of the adjuster may be offset from thedriver to allow the adjuster to accommodate elongated members withvarious curvatures. When the desired separation distance is established,the driver may be used to secure the closure member to the elongatedmember and second bone fastener assembly.

In some embodiments, the adjuster may include an engagement mechanism.In a first position, the engagement mechanism may allow a first handleof the adjuster to translate towards or away from a second handle of theadjuster. In a second position, the engagement mechanism may inhibittranslation of the first handle relative to the second handle. Theengagement mechanism may facilitate coupling the adjuster and the driverto the first extender and the second extender. In embodiments where theadjuster is a compressor, the engagement mechanism may also allow a userto establish a separation distance between the driver and an end surfaceof the compressor. The established separation distance may allow thedriver to rotate towards the compressor to allow for compression of thevertebral bodies.

Imaging techniques may be used to confirm the position of the installedspinal stabilization system. When the spinal stabilization system ispositioned as desired, a driver may be used to shear off tool portionsof closure members. A counter torque wrench may be used to counteractforce applied to the spinal stabilization system so that the forceapplied to shear the tool portion of a closure member is not transmittedto the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

Advantages of the present invention will become apparent to thoseskilled in the art with the benefit of the following detaileddescription and upon reference to the accompanying drawings in which:

FIG. 1 depicts a perspective view of an embodiment of a spinalstabilization system.

FIG. 2 depicts a perspective view of an embodiment of a bone fastenerassembly.

FIG. 3 depicts a perspective view of an embodiment of a bone fastener.

FIG. 4 depicts a perspective view of an embodiment of a bone fastenerassembly ring.

FIG. 5 depicts a perspective view of an embodiment of a bone fastenerassembly collar.

FIG. 6 depicts a cross-sectional view of an embodiment of a bonefastener assembly.

FIG. 7 depicts a front view of an embodiment of a bone fastener assemblywith a collar that allows for angulation of a bone fastener relative tothe collar in a conical range of motion that is symmetrical relative toan axis that passes through a central axis of the collar and a centralaxis of a bone fastener.

FIG. 8 depicts a perspective view of an embodiment of a closure member.

FIG. 9 depicts a cross-sectional representation of the closure membertaken substantially along plane 9-9 indicated in FIG. 8.

FIG. 10 depicts a perspective view of an embodiment of a portion of aspinal stabilization system.

FIG. 11 depicts a perspective view of an embodiment of a multi-channelextender.

FIG. 12 depicts a top view of an embodiment of a multi-channel extenderwith a bone fastener assembly coupled to the extender.

FIG. 13 depicts a cross-sectional representation of a portion of theextender and bone fastener assembly taken substantially along line 13-13of FIG. 12.

FIG. 14 depicts a cross-sectional representation of a portion of theextender with the bone fastener assembly taken substantially along line14-14 of FIG. 12.

FIG. 15 depicts a perspective view of an embodiment of a single-channelextender.

FIG. 16 depicts a perspective view of an embodiment of extenders coupledto bone fastener assemblies.

FIG. 17 depicts a perspective view of an embodiment of an adjuster.

FIG. 18 depicts a top view representation of an embodiment of anadjuster.

FIG. 19 depicts an embodiment of the adjuster shown in FIG. 17 with adriver inserted through an opening in the adjuster.

FIG. 20 depicts a side view of an embodiment of an adjuster.

FIG. 21 depicts a perspective view of the embodiment of the adjustershown in FIG. 20.

FIG. 22 depicts a side view of an embodiment of an adjuster coupled toextenders that are coupled to a spinal stabilization system

FIG. 23 depicts a perspective view of the adjuster shown in FIG. 22 witha driver inserted through one of the handles of the adjuster.

FIG. 24 depicts a perspective view of an embodiment of an adjuster.

FIG. 25 depicts a cutaway view of an embodiment of an engagementmechanism for the adjusters shown in FIG. 24 and FIG. 28.

FIG. 26 depicts a top, cutaway view of a portion of the adjusters shownin FIG. 24 and FIG. 28.

FIG. 27 depicts a top cutaway view of a portion of the adjusters shownin FIG. 24 and FIG. 28.

FIG. 28 depicts a perspective view of an embodiment of an adjuster.

FIG. 29 depicts an embodiment of an elongated member.

FIG. 30 depicts an embodiment of an elongated member.

FIG. 31 depicts an embodiment of an elongated member.

FIG. 32 depicts an embodiment of an elongated member.

FIG. 33 depicts an embodiment of a spinal stabilization system beforecompression.

FIG. 34 depicts an embodiment of an adjuster with a shaft of theadjuster inserted in an extender coupled to a spinal stabilizationsystem.

FIG. 35 depicts an embodiment of an adjuster with a shaft of theadjuster and a driver inserted in extenders coupled to a spinalstabilization system before compression.

FIG. 36 depicts an embodiment of an adjuster following compression of asingle-level spinal stabilization system.

FIG. 37 depicts an embodiment of an adjuster during a stage ofcompression of a multilevel spinal stabilization system.

FIG. 38 depicts an embodiment of an adjuster with a shaft of theadjuster inserted in an extender coupled to a spinal stabilizationsystem.

FIG. 39 depicts an embodiment of an adjuster with a shaft of theadjuster and a driver inserted in extenders coupled to a spinalstabilization system before distraction.

FIG. 40 depicts an embodiment of an adjuster following distraction.

While the invention is susceptible to various modifications andalternative forms, specific embodiments thereof are shown by way ofexample in the drawings and will herein be described in detail. Thedrawings may not be to scale. It should be understood that the drawingsand detailed description thereto are not intended to limit the inventionto the particular form disclosed, but on the contrary, the intention isto cover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the present invention as defined by the appendedclaims.

DETAILED DESCRIPTION

A spinal stabilization system may be installed in a patient to stabilizea portion of a spine. Spinal stabilization may be used, but is notlimited to use, in patients having degenerative disc disease, spinalstenosis, spondylolisthesis, pseudoarthrosis, and/or spinal deformities;in patients having fracture or other vertebral trauma; and in patientsafter tumor resection. A spinal stabilization system may be installedusing a minimally invasive procedure. An instrumentation set may includeinstruments and spinal stabilization system components for forming aspinal stabilization system in a patient and for facilitatingcompression or distraction of one or more vertebral bodies.

A minimally invasive procedure may be used to limit an amount of traumato soft tissue surrounding vertebrae that are to be stabilized. In someembodiments, the natural flexibility of skin and soft tissue may be usedto limit the length and/or depth of an incision or incisions neededduring the stabilization procedure. Minimally invasive procedures mayprovide limited direct visibility in vivo. Forming a spinalstabilization system using a minimally invasive procedure may includeusing tools to position system components in the body.

A minimally invasive procedure may be performed after installation ofone or more spinal implants in a patient. The spinal implant or spinalimplants may be inserted using an anterior procedure and/or a lateralprocedure. The patient may be turned and a minimally invasive proceduremay be used to install a posterior spinal stabilization system. Aminimally invasive procedure for stabilizing the spine may be performedwithout prior insertion of one or more spinal implants or devices insome patients. In some patients, a minimally invasive procedure may beused to install a spinal stabilization system after one or more spinalimplants are inserted using a posterior spinal approach.

A spinal stabilization system may be used to achieve rigid pediclefixation while minimizing the amount of damage to surrounding tissue. Insome embodiments, a spinal stabilization system may be used to providestability to two adjacent vertebrae (i.e., one vertebral level). Aspinal stabilization system may include two bone fastener assemblies.One bone fastener assembly may be positioned in each of the vertebrae tobe stabilized. An elongated member may be coupled and secured to thebone fastener assemblies. As used herein, “coupled” components maydirectly contact each other or may be separated by one or moreintervening members. In some embodiments, a single spinal stabilizationsystem may be installed in a patient. Such a system may be referred toas a unilateral, single-level stabilization system or a single-level,two-point stabilization system. In some embodiments, two spinalstabilization systems may be installed in a patient on opposite sides ofa spine. Such a system may be referred to as a bilateral, single-levelstabilization system or a single-level, four-point stabilization system.

In some embodiments, a spinal stabilization system may provide stabilityto three or more vertebrae (i.e., two or more vertebral levels). In atwo vertebral level spinal stabilization system, the spinalstabilization system may include three bone fastener assemblies. Onebone fastener assembly may be positioned in each of the vertebrae to bestabilized. An elongated member may be coupled and secured to the threebone fastener assemblies. In some embodiments, a single two-level spinalstabilization system may be installed in a patient. Such a system may bereferred to as a unilateral, two-level stabilization system or atwo-level, three-point stabilization system. In some embodiments, twothree-point spinal stabilization systems may be installed in a patienton opposite sides of a spine. Such a system may be referred to as abilateral, two-level stabilization system or a two-level, six-pointstabilization system.

In some embodiments, combination systems may be installed. For example,a two-point stabilization system may be installed on one side of aspine, and a three-point stabilization system may be installed on theopposite side of the spine. The composite system may be referred to afive-point stabilization system.

Minimally invasive procedures may reduce trauma to soft tissuesurrounding vertebrae that are to be stabilized. Only a small openingmay need to be made in a patient. For example, for a single-levelstabilization procedure on one side of the spine, the surgical proceduremay be performed through a 2 cm to 4 cm incision formed in the skin ofthe patient. In some embodiments, the incision may be above and betweenthe vertebrae to be stabilized. Dilators, a targeting needle, and/or atissue wedge may be used to provide access to the vertebrae to bestabilized without the need to form an incision with a scalpel throughmuscle and other tissue between the vertebrae to be stabilized. Aminimally invasive procedure may reduce an amount of post-operative painfelt by a patient as compared to invasive spinal stabilizationprocedures. A minimally invasive procedure may reduce recovery time forthe patient as compared to invasive spinal procedures.

Components of spinal stabilization systems may be made of materialsincluding, but not limited to, titanium, titanium alloys, stainlesssteel, ceramics, and/or polymers. Some components of a spinalstabilization system may be autoclaved and/or chemically sterilized.Components that may not be autoclaved and/or chemically sterilized maybe made of sterile materials. Components made of sterile materials maybe placed in working relation to other sterile components duringassembly of a spinal stabilization system.

Spinal stabilization systems may be used to correct problems in lumbar,thoracic, and/or cervical portions of a spine. Various embodiments of aspinal stabilization system may be used from the C1 vertebra to thesacrum. For example, a spinal stabilization system may be implantedposterior to the spine to maintain distraction between adjacentvertebral bodies in a lumbar portion of the spine.

FIG. 1 depicts an embodiment of spinal stabilization system 100 that maybe implanted using a minimally invasive surgical procedure. Spinalstabilization system 100 may include bone fastener assemblies 102,elongated member 104, and/or closure members 106. Other spinalstabilization system embodiments may include, but are not limited to,plates, dumbbell-shaped members, and/or transverse connectors. FIG. 1depicts a spinal stabilization system for one vertebral level. In someembodiments, the spinal stabilization system of FIG. 1 may be used as amulti-level spinal stabilization system if one or more vertebrae arelocated between the vertebrae in which bone fastener assemblies 102 areplaced. In other embodiments, multi-level spinal stabilization systemsmay include additional bone fastener assemblies to couple to one or moreother vertebrae.

FIG. 2 depicts a perspective view of bone fastener assembly 102. FIGS.3-5 depict embodiments of bone fastener assembly components. Componentsof bone fastener assembly 102 may include, but are not limited to, bonefastener 108 (shown in FIG. 3), ring 110 (shown in FIG. 4), and collar112 (shown in FIG. 5). Bone fastener 108 may couple bone fastenerassembly 102 to a vertebra. Ring 110 may be positioned between a head ofbone fastener 108 and collar 112.

FIG. 6 depicts a cross-sectional representation of bone fastener 108,ring 110, and collar 112 of bone fastener assembly 102. Bone fastener108 of bone fastener assembly 102 may include passage 114. A guide wiremay be placed through passage 114 so that bone fastener 108 may beinserted into a vertebra at a desired location and in a desired angularorientation relative to the vertebra with limited or no visibility ofthe vertebra.

A bone fastener may be, but is not limited to, a bone screw, a ringshank fastener, a barb, a nail, a brad, or a trocar. Bone fastenersand/or bone fastener assemblies may be provided in various lengths in aninstrumentation set to accommodate variability in vertebral bodies. Forexample, an instrumentation set for stabilizing vertebrae in a lumbarregion of the spine may include bone fastener assemblies with lengthsranging from about 30 mm to about 75 mm in 5 mm increments.

FIG. 3 depicts an embodiment of bone fastener 108. Bone fastener 108 mayinclude shank 116, head 118, and neck 120. Shank 116 may includethreading 122. In some embodiments, threading 122 may includeself-tapping start 124. Self-tapping start 124 may facilitate insertionof bone fastener 108 into vertebral bone.

Head 118 of bone fastener 108 may include various configurations toengage a driver that inserts the bone fastener into a vertebra. In someembodiments, the driver may also be used to remove an installed bonefastener from a vertebra. In some embodiments, head 118 may include oneor more tool portions 126. Tool portions 126 may be recesses and/orprotrusions designed to engage a portion of the driver.

Head 118 of bone fastener 108 may include one or more splines 128, asdepicted in FIG. 3. In some head embodiments, head 118 may include threesplines. Splines 128 may be equally spaced circumferentially around head118 of bone fastener 108. In some head embodiments, splines 128 may bespaced at unequal distances circumferentially around head 118. Splines128 may include various surface configurations and/or texturing toenhance coupling of bone fastener 108 with a ring of a bone fastenerassembly. In some embodiments, sides of the splines may be tapered sothat the splines form a dovetail connection with a ring. In someembodiments, spline width may be tapered so that a good interferenceconnection is established when the bone screw is coupled to a ring.Splines 128 may include one or more projections 130 to facilitatecoupling bone fastener 108 with an inner surface of a ring. In someembodiments, projections 130 may be positioned on a lower portion ofsplines 128. In some embodiments, the splines may include recessedsurfaces that accept projections extending from surfaces of the ring.

Neck 120 of bone fastener 108 may have a smaller diameter than adjacentportions of head 118 and shank 116. The diameter of neck 120 may fix themaximum angle that the collar of the bone fastener assembly can berotated relative to bone fastener 108. In some embodiments, neck 120 maybe sized to allow up to about 40.degree. or more of angulation of thecollar relative to the bone fastener. In some embodiments, the neck maybe sized to allow up to about 30.degree. of angulation of the collarrelative to the bone fastener. In some embodiments, the neck may besized to allow up to about 20.degree. of angulation of the collarrelative to the bone fastener.

FIG. 4 depicts a perspective view of an embodiment of ring 110. Outersurface 132 of ring 110 may have a contour that substantiallycomplements a contour of an inner surface of a collar in which the ringresides. A contour of the outer surface of the ring may be a sphericalportion. When the ring is positioned in the collar, the complementaryshape of the ring outer surface and the inner surface of the collar thatcontacts the ring allows angulation of the collar relative to a bonefastener coupled to the ring. The contour of the outer surface of thering and the inner surface of the collar may inhibit removal of the ringfrom the collar after insertion of the ring into the collar.

Outer surface 132 of ring 110 may have a smooth finish. In someembodiments, outer surface 132 may be surface treated or includecoatings and/or coverings. Surface treatments, coatings, and/orcoverings may be used to adjust frictional and/or wear properties of theouter surface of the ring.

An inner surface of ring 110 may include one or more grooves 134 and/orone or more seats 136. Seats 136 may be circumferentially offset fromgrooves 134. Grooves 134 may be sized to allow passage of splines of abone fastener (e.g., splines 128 shown in FIG. 3) through the ring. Whenthe splines are inserted through grooves 134, the bone fastener may berotated until the splines align with seats 136. The bone fastener may bepulled or driven so that the splines are positioned in seats 136. Insome embodiments, projections (e.g., projections 130 in FIG. 3) may passover ridges 138 of ring 110. Passage of the projections over ridges 138may securely couple the bone fastener to the ring and inhibit separationof the ring from the bone fastener.

In a ring embodiment, a number of grooves 134 and a number of seats 136may equal a number of splines 128 on a head of a bone fastener. Seats136 and grooves 134 may be equally spaced circumferentially around theinner surface of ring 110. In some embodiments, seats 136 may becircumferentially offset about 600 from grooves 134.

As used herein, the term “collar” includes any element that wholly orpartially encloses or receives one or more other elements. A collar mayenclose or receive elements including, but not limited to, a bonefastener, a closure member, a ring, and/or an elongated member. In someembodiments, a collar may couple two or more other elements together(e.g., an elongated member and a bone fastener). A collar may have anyof various physical forms. In some embodiments, a collar may have a “U”shape, however it is to be understood that a collar may also have othershapes.

Collar 112 may include body 140 and arms 142. Arms 142 may extend frombody 140. Body 140 of collar 112 may be greater in width than a widthacross arms 142 of collar 112 (i.e., body 140 may have a maximumeffective outer diameter greater than a maximum effective outer diameterof arms 142). A reduced width across arms 142 may allow an extender tobe coupled to the arms without substantially increasing a maximumeffective outer diameter along a length of collar 112. Thus, a reducedwidth across arms 142 may reduce bulk at a surgical site.

Inner surfaces of arms 142 may include threading 144. Threading 144 mayengage complementary threading of a closure member to secure anelongated member to a bone fastener assembly.

Arms 142 and body 140 may form slot 146. Slot 146 may be sized toreceive an elongated member. When an elongated member is positioned inslot 146, a portion of the elongated member may contact a head of a bonefastener positioned in the collar.

Arms 142 may include ridges or flanges 148. Flange 148 may allow collar112 to be coupled to an extender so that translational motion of thecollar relative to the extender is inhibited. Flanges 148 may alsoinclude notches 150. A movable member of an extender may extend intonotch 150. When the movable member is positioned in notch 150, a channelin the extender may align with a slot in collar 112. With the movablemember positioned in notch 150, rotational movement of collar 112relative to the extender may be inhibited.

A bone fastener may be positioned in a collar such that the bonefastener is able to move radially and/or rotationally relative to thecollar (or the collar relative to the bone fastener) within a definedrange of motion. Motion of the bone fastener relative to the collar (orthe collar relative to the bone fastener) may be referred to as“angulation” and/or “polyaxial movement”.

FIG. 7 depicts bone fastener assembly 102 with central axis 152 ofcollar 112 aligned with central axis 154 of bone fastener 108. Bonefastener 108 may be angulated in a symmetrical conical range of motioncharacterized by angle a. about the aligned axes. Bone fastener 108 maybe constrained from motion outside of limit axis 156 by contact betweenneck 120 of bone fastener 108 and collar 112. Alignment of axis 154 ofbone fastener 108 with central axis 152 of collar 112 may be considereda neutral position relative to the range of motion. The alignment is aneutral position because bone fastener 108 may be angulated an equalamount in any direction from central axis 152. When a driver is coupledto bone fastener 108, axis 154 of bone fastener 108 may be substantiallyaligned with axis 152 of collar 112 to facilitate insertion of the bonefastener into a vertebral body.

A closure member may be coupled to a collar of a bone fastener assemblyto fix an elongated member positioned in the collar to the bone fastenerassembly. FIG. 1 depicts closure members 106 coupled to bone fastenerassemblies 102. FIG. 8 depicts closure member 106 prior to insertion ofthe closure member into a collar of a bone fastener assembly. Closuremember 106 may include tool portion 158 and male threading 160. Toolportion 158 may couple to a tool that allows closure member 106 to bepositioned in a collar. Tool portion 158 may include variousconfigurations (e.g., threads, hexalobular connections, hexes) forengaging a tool (e.g., a driver). Male threading 160 may have a shapethat complements the shape of female threading in arms of a collar(e.g., threading 144 depicted in FIG. 5).

FIG. 9 depicts a cross-sectional representation of closure member 106taken substantially along plane 9-9 of FIG. 8. Closure member 106 mayinclude removal openings 162. A drive tool may be inserted into removalopenings 162 to allow removal of closure member 106 after tool portion158 has been sheared off. Removal openings 162 may include any of avariety of features including, but not limited to, sockets, holes,slots, and/or combinations thereof. In an embodiment, removal openings162 are holes that pass through bottom surface 164 of closure member106.

A bottom surface of a closure member may include structure and/ortexturing that promotes contact between the closure member and anelongated member. A portion of the structure and/or texturing may enterand/or deform an elongated member when the closure member is coupled tothe elongated member. Having a portion of the closure member enterand/or deform the elongated member may couple the elongated member tothe closure member and a bone fastener assembly so that movement of theelongated member relative to the bone fastener assembly is inhibited. Ina closure member embodiment, such as the embodiment depicted in FIG. 9,bottom surface 164 of closure member 106 may include point 166 and rim168. In some embodiments, rim 168 may come to a sharp point. In someembodiments, a height of rim 168 may be less than a height of point 166.In other embodiments, a height of rim 168 may be the same or larger thana height of point 166. In some embodiments, rim 168 may not extendcompletely around the closure member. For example, eight or moreportions of rim 168 may be equally spaced circumferentially aroundclosure member 106. In certain embodiments, a solid central coreincluding point 166 and rim 168 may enhance the ability of closuremember 106 to secure an elongated member in a collar.

FIG. 10 depicts a portion of a spinal stabilization system with closuremember 106 coupled to collar 112 before tool portion 158 is sheared off.Closure member 106 may couple to collar 112 by a variety of systemsincluding, but not limited to, standard threads, modified threads,reverse angle threads, buttress threads, or helical flanges. Closuremember 106 may be advanced into an opening in a collar to engage aportion of elongated member 104. In some embodiments, closure member 106may inhibit movement of elongated member 104 relative to collar 112.

Various instruments may be used in a minimally invasive procedure toform a spinal stabilization system in a patient. The instruments mayinclude, but are not limited to, positioning needles, guide wires,dilators, bone awls, bone taps, sleeves, extenders, drivers, tissuewedges, elongated member length estimating tools, mallets, tissueretractors, and tissue dilators. The instruments may be provided in aninstrumentation set. The instrumentation set may also include componentsof the spinal stabilization system: The components of the spinalstabilization system may include, but are not limited to, bone fastenerassemblies of various sizes and/or lengths, elongated members, andclosure members.

Instruments used to install a spinal stabilization system may be made ofmaterials including, but not limited to, stainless steel, titanium,titanium alloys, ceramics, and/or polymers. Some instruments may beautoclaved and/or chemically sterilized. Some instruments may be, or mayinclude, components that cannot be autoclaved or chemically sterilized.Instruments or components of instruments that cannot be autoclaved orchemically sterilized may be made of sterile materials.

An extender may be used as a guide to install bone fasteners of a bonefastener assembly in vertebral bone. An extender may be coupled to acollar of a bone fastener assembly. A distal end of an extender may betapered or angled to reduce bulk at a surgical site. Instruments may beinserted into the extender to manipulate the bone fastener assembly.Movement of the extender may alter an orientation of a collar relativeto a bone fastener of the bone fastener assembly. In some embodiments,an extender may be used as a retractor during a spinal stabilizationprocedure.

An extender for a single-level vertebral stabilization system mayinclude one or more channels in a wall of the extender to allow accessto an adjacent vertebra. For some single-level vertebral stabilizationprocedures, only single-channel extenders (i.e., extenders with a singlechannel in a wall of the extender) may be used. For other single-levelvertebral stabilization procedures, one or more multi-channel extenders(i.e., extenders with two or more channels in a wall of the extender)may be used. Channels may provide flexibility to or enhance flexibilityof a multi-channel extender. In some embodiments, a proximal portion ofa multi-channel extender may have a solid circumference. A region ofsolid circumference in a multi-channel extender 16 may enhance stabilityof the multi-channel extender. In some embodiments, a multi-channelextender may be longer than a single-channel extender.

An extender used at a middle vertebra in a multi-level stabilizationprocedure may be a multi-channel extender. Channels in a multi-channelextender may allow access to adjacent vertebrae from a middle vertebra.An extender used at an end vertebra of a multi-level stabilizationsystem may be a single-channel extender or a multi-channel extender. Asystem for coupling a bone fastener assembly to a multi-channel extendermay include a limiter that inhibits spreading of anus of the extender toinhibit release of the bone fastener assembly from the extender.

Instruments may access a bone fastener assembly through a passage in anextender. In some embodiments, a channel in a wall of an extender mayextend a full length of the extender. In some embodiments, especially inembodiments of multi-channel extenders, a channel in a wall of anextender may extend only a portion of the length of the extender. Achannel may extend to a distal end of an extender such that an elongatedmember inserted in the channel may pass from the extender into a slot ofa collar of a bone fastener assembly coupled to the extender.

A channel in an extender may be any of a variety of shapes. A channelmay have a width that exceeds a width (e.g., a diameter) of an elongatedmember that is to be inserted in the channel. In some embodiments, achannel may be a linear opening parallel to a longitudinal axis of theextender.

Movable members may extend through portions of an extender proximate achannel in the extender. Movable members may engage notches in a collarto establish a radial orientation of the extender on the collar and/orto inhibit rotation of the collar relative to the extender. In someembodiments, a distal end of a movable member may be a projection thatengages an opening in a collar. In certain embodiments, a proximal endof a movable member may include a tool portion. The tool portion mayfacilitate engaging the collar with the extender.

FIG. 11 depicts an embodiment of extender 170. Extender 170 may be amulti-channel extender. Extender 170 may include wall 172, channels 174,passage 176, movable members 178, and flange 180. Channels 174 mayextend from a distal end of extender 170 through a portion of wall 172.Channels 174 may allow instruments to be positioned and used to form aplane through soft tissue to one or more adjacent vertebrae. Anelongated member may be inserted in the tissue plane and positioned incollars of bone fastener assemblies anchored in vertebrae and coupled toextenders. Passage 176 may allow instruments to be positioned and usedto manipulate a bone fastener assembly that is coupled to a distal endof extender 170. Movable members 178 may be part of a system thatcouples a bone fastener assembly to extender 170. In some embodiments,movable members 178 may include tool portion 182. A driver may bepositioned in tool portion 182. The driver (e.g., a hex wrench) may beused to extend or retract a distal end of movable member 178. A distalend of extender 170 may include flange 180 that mates with acomplementary flange on a collar of a bone fastener assembly. A distalend of extender 170 may be tapered to reduce bulk (e.g., reduce spindiameter) at a surgical site.

FIG. 12 depicts a top view of an embodiment of extender 170 coupled to abone fastener assembly. Tool portion 126 of bone fastener 108 is ahexalobular connection.

FIG. 13 depicts a cross-sectional representation of a portion ofextender 170 with bone fastener assembly 102 taken substantially alongline 13-13 of FIG. 12. Flange 180 of extender 170 may mate with flange148 of collar 112 to inhibit translation of the extender relative to thecollar. Extender 170 may also include stop 184. Stop 184 may engage aportion of collar 112 to inhibit separation of walls 172. During use,stop 184 may inhibit undesired separation of bone fastener assembly 102from extender 170.

FIG. 14 depicts a cross-sectional representation of a portion ofextender 170 with bone fastener assembly 102 and elongated member 104taken substantially along line 14-14 of FIG. 12. Distal ends of movablemembers 178 may extend into notches (e.g., notches 150 depicted in FIG.5) in collar 112. Portions of walls 172 of extender 170 may includethreading. Portions of movable members 178 may include threadingcomplementary to threaded portions of walls 172. Threading of movablemembers 178 may engage threading in walls 172 such that rotation of themovable members advances or retracts the movable members relative to thewalls.

As shown in FIG. 14, collar 112 may be designed such that elongatedmember 104 lies below a distal end of extender 170. Coupling extender170 to collar 112 above elongated member 104 may reduce bulk at asurgical site. With elongated member 104 coupled to collar 112 below adistal end of extender 170, the extender may be removed withoutinterference from the elongated member of a spinal stabilization system.

FIG. 15 depicts an embodiment of extender 170. Extender 170 may be asingle-channel extender for use in single-level or multi-level spinalstabilization procedures. Extender 170 may be used at the outermostvertebrae to be stabilized during installation of a multi-levelvertebral stabilization system. Extender 170 may be coupled to a collarof a bone fastener assembly with movable members 178 and/or flange 180.Instruments may be inserted through passage 176 of extender 170 toaccess an anchored bone fastener assembly coupled to the extender. Aninstrument may be moved through channel 174 toward an adjacent vertebrato form a tissue plane in soft tissue between extender 170 and theadjacent vertebra.

An extender may be coupled to a collar of a bone fastener assembly invarious ways. When an extender is coupled to a collar, rotation andtranslation of the extender relative to the collar may be inhibited. Asystem used to couple an extender and collar should be simple,inexpensive to implement, and should not significantly weaken themechanical strength of the collar and/or the extender. Extenders may becoupled to collars using various coupling systems including, but notlimited to, flanges, threaded connections, interlocking connections(e.g., ratcheting connection systems), and/or interference fits.

Extenders may be of various lengths. Extenders of different lengths maybe used in the same surgical procedure, An extender length used in aspinal stabilization procedure may be determined by a patient's anatomy,Extenders may be just short enough to allow manipulation by a medicalpractitioner above an incision in a patient. A multi-channel extendermay be longer than a single-channel extender.

When bone fasteners of poly axial bone fastener assemblies arepositioned in vertebral bone, extenders coupled to collars of the bonefastener assemblies may be moved in desired positions. During surgery,an extender in a patient may be oriented towards an adjacent vertebrathat is to be stabilized to reduce the required incision size. In someembodiments, channels of the extenders may be aligned so that anelongated member may be positioned in collars of the bone fastenerassemblies. FIG. 16 depicts an orientation of three extenders. Extenders170, 170′ may couple to collars 112, 112′. Bone fasteners 108, 108′ maybe inserted into vertebrae. Single-channel extenders 170 may be coupledto collars 112 before insertion of bone fasteners 108 into two outerpedicles to be stabilized. Multi-channel extender 170′ may be coupled tocollar 112′ before insertion of bone fastener 108′ into a centralpedicle of the three adjacent pedicles. Single-channel extenders 170 maybe angled towards multi-channel extender 170′. Channels of the extendersmay be aligned so that an elongated member may be moved down theextenders and into collars of the bone fastener assemblies.

After a bone fastener assembly is coupled to an extender, a driver maybe coupled to a bone fastener of the bone fastener assembly. The drivermay be used to insert the bone fastener into vertebral bone.

After bone fastener assemblies are installed and an elongated member isplaced in the bone fastener assemblies, closure members may be securedto the bone fastener assemblies. When a closure member is threaded on abone fastener assembly, a counter torque wrench may be used to inhibitthe application of torque to the spine of the patient. A counter torquewrench may hold an extender that is coupled to a collar as the toolportion of a closure member is sheared off. In certain embodiments,about 90 in-lbs of torque may be required to shear off the tool portionof a closure member.

During some spinal stabilization procedures, an instrument may be usedto adjust a separation distance between vertebrae. The instrument may bean adjuster. An adjuster is any instrument used to change the separationdistance between vertebral bodies, hold the vertebral bodies at adesired separation distance, and allow the vertebral bodies to be atleast temporarily secured to maintain the separation distance. Anadjuster may couple to extenders that are connected to a spinalstabilization system. The spinal stabilization system may be asingle-level or a multi-level spinal stabilization system. Establishinga desired separation distance with the adjuster may be achieved, but isnot limited to being achieved, by the use of threading, cams, linkagearms, levers, or combinations thereof. In some adjuster embodiments, theadjuster may be a compressor that reduces a distance between vertebrae.In some embodiments, the adjuster may be a distractor that increases adistance between vertebrae. Some adjuster embodiments may be able toreduce a distance between vertebrae, as well as being able to increase adistance between vertebrae.

During some spinal stabilization procedures, an adjuster may be used totranslate a first vertebral body toward an adjacent vertebral body tocompress the vertebrae. Compression may be performed for many reasons.For example, compression of a vertebra toward an adjacent vertebra mayadd a compressive load to a fusion device between the vertebrae toreduce the risk of expulsion of the device and/or to increase the rateof bone fusion. The adjuster may translate a first vertebra towards asecond vertebra to achieve compression. Compression may includetranslating one bone fastener assembly along an elongated member of aspinal stabilization system toward another bone fastener assembly of thespinal stabilization system. A final position of the compressedvertebrae may be maintained by securing the elongated member in a collarof the translated bone fastener assembly with a closure member.

During some spinal stabilization procedures, an adjuster may be used toincrease a separation distance between a first vertebral body and asecond vertebral body to distract the vertebrae. Distraction may beperformed for many reasons. For example, a first vertebra may beseparated from a second vertebra to establish a desired separationdistance between the vertebrae. The adjuster may translate the firstvertebra away from the second vertebra to achieve distraction.Distraction may include translating one bone fastener assembly along anelongated member of a spinal stabilization system away from another bonefastener assembly of the spinal stabilization system. A final positionof the distracted vertebrae may be maintained by securing the elongatedmember in a collar of the translated bone fastener assembly with aclosure member.

FIG. 17 depicts a perspective view of an embodiment of an adjusterdesigned to pivot above a surface of the skin during use. FIG. 18depicts a top view of the adjuster embodiment depicted in FIG. 17.Adjuster 186 may include handle 188, shaft 190, pivot 192 and pivotholder 194. Shaft 190 may be coupled to handle knob 188. Pivot 192 maybe free to rotate in holder 194. Opening 196 in pivot 192 may be sizedto accept a shaft of a driver for a closure member.

Prior to use of the adjuster embodiment depicted in FIG. 17, a closuremember may be coupled to a collar of a first bone fastener assemblypositioned in a first vertebra. A driver may be used to tighten theclosure member so that movement of an elongated member positioned in thecollar is inhibited. A closure member may be coupled to a collar of asecond bone fastener assembly that is positioned in a second vertebra.The collar in the second bone fastener assembly may be tightened withthe driver until the closure member contacts the elongated member. Then,the closure member may be backed off from 0.5 to 2.5 turns so that thecollar of the second bone fastener assembly can be translated relativeto the elongated member.

The shaft of the driver may be positioned in the opening 196 of adjuster186. Shaft 190 of adjuster 186 may be positioned in an extender coupledto the collar of the first bone fastener assembly. FIG. 19 depicts shaft190 of adjuster 186 positioned in extender 170. The diameter of theshaft is sized to prevent the shaft from exiting a channel in extender170. The shaft of driver 198 may be inserted in extender 170′ that iscoupled to the collar of the second bone fastener assembly. The shaft ofdriver 198 may have a diameter that prevents the shaft from exiting achannel in extender 170′. In some embodiments, driver 198 may be rotatedabout the pivot of adjuster 186 to move the vertebra coupled to thesecond bone fastener assembly towards the vertebra coupled to the firstbone fastener assembly to achieve compression. In some embodiments,driver 198 may be rotated about the pivot of adjuster 186 to move thevertebra coupled to the second bone fastener assembly away from thevertebra coupled to the first bone fastener assembly to achievedistraction. When a desired amount of compression or distraction isachieved, driver 198 may be used to tighten the closure member in thesecond bone fastener assembly to fix the position of the second bonefastener assembly relative to the elongated member.

In some embodiments, a pivot of the adjuster may not be offset to theside of a shaft of the adjuster. A pivot of the adjuster may be locatedin front of the shaft. Walls of the handle adjacent to the pivot may betapered or recessed to allow a shaft of a driver positioned in the pivotto rotate in a desired working range.

FIG. 20 depicts an adjuster embodiment that may be used as a compressor.Adjuster 186 may be designed such that forces applied to the extendersand the vertebrae are substantially directly opposed to each otherduring use (e.g., the extenders are in line during compression ordistraction). Adjuster 186 may include handles 200, 202. Outer sleeve204 coupled to handle 200 may provide an opening for a driver to accessa closure member positioned in a first extender coupled to a collar of aspinal stabilization system. A portion of handle 202 may fit in aportion of handle 200. In some embodiments, handle 202 may move (e.g.,pivot, translate) relative to handle 200 about member 206.

Outer sleeve 204 of handle 200 may be positioned over an extendercoupled to a spinal stabilization system. With outer sleeve 204positioned over an extender coupled to a spinal stabilization system,sliding shaft 208 may be retracted into handle 202. FIG. 21 depictssliding shaft 208 retracted into handle 202 of adjuster 186. Handle 202may pivot about and/or translate relative to member 206 such thatsliding shaft 208 may be adjustably positioned in a second extendercoupled to the spinal stabilization system. With handle 202 positionedsuch that sliding shaft 208 is aligned above extender 170, the slidingshaft may be inserted in the extender. FIG. 22 depicts adjuster 186 withsliding shaft 208 positioned in extender 170. With sliding shaft 208positioned in extender 170 and extender 170′ positioned in outer sleeve204, handles 200, 202 may be compressed. Compressing handles 200, 202may translate collar 112′ toward collar 112 along elongated member 104.Driver 198, depicted in FIG. 23, may be used to tighten a closure memberto collar 112′ to secure the spinal stabilization system in the desiredcompressed configuration.

FIG. 24 depicts an embodiment of adjuster 186 that may be used as acompressor. In some embodiments, adjuster 186 may include an adjustablepivot axis. Adjuster 186 may include handles 210, 212. Adjuster 186 mayinclude a bias system. In some embodiments, the bias system includestension members 214 coupled to handles 210, 212. Tension members 214 mayprovide a force to handles 210, 212 that separates the handles. Handle210 may align with handle 212 so that forces applied to the handles aredirectly opposed, thus eliminating or substantially eliminatingtorsional forces during use. Handle 210 may be coupled to an extenderengager. In some embodiments, the extender engager may be shaft 216. Insome embodiments, the extender engager may be a hollow shaft that fitsover an extender. Shaft 216 may be positioned in a first extender thatis coupled to a first collar secured to an elongated member of a spinalstabilization system.

Handle 212 may include a driver engager. The driver engager may couple aclosure member driver to the adjuster. A portion of the closure memberdriver may be inserted in a second extender that is secured to a secondcollar when an extender engager of the adjuster is coupled to a firstextender that is secured to a first collar. In some embodiments, thedriver engager may be one or more rings coupled to handle 212 into whichthe driver is inserted. In an embodiment, the driver engager may bepassage 218. A closure member may be coupled to the closure memberdriver. The closure member may be inserted through passage 218 into thesecond extender. The closure member may be coupled to the second collar.In some embodiments, the closure member driver may be affixed to theadjuster so that separation of the driver from the adjuster isinhibited.

In some adjuster embodiments, handles 210, 212 of adjuster 186 may beable to translate towards each other. Translation may be allowed orinhibited by engagement mechanism 220. When engagement mechanism 220allows for translation, the position of handle 212 may be adjustedrelative to the position of handle 210. The ability of handle 212 totranslate towards handle 210 may facilitate insertion of the adjusterand a shaft of a driver coupled to the adjuster into extenders that aresecured to collars of a spinal stabilization system.

FIG. 25 depicts a partial cut-away view of engagement mechanism 220 withhandle 212. For clarity, handle 210 is not depicted in FIG. 25.Engagement mechanism 220 may include knob 222. Knob 222 may be coupledto shaft 224. Shaft 224 may be positioned through opening 226 in handle212. A portion of shaft 224 may be threaded. In some embodiments, endmember 228 may be coupled to shaft 224. In some embodiments, movablemember 230 may be positioned on shaft 224 between end member 228 andknob 222. End member 228 may inhibit removal of movable member 230,shaft 224, and knob 222 from the adjuster. Movable member 230 may havethreading that mates with threading of shaft 224. Movable member 230 maybe complementary to a portion of opening 232 in handle 212 to inhibitrotation of the movable member relative to knob 222. In someembodiments, rotation of knob 222 in a first direction may draw movablemember 230 toward protrusions 234 on handle 212. Protrusions 236 onmovable member 230 may engage (e.g., mate or interlock with) protrusions234 in handle 212 as knob 222 is rotated. Tightening knob 222 mayinhibit translation of handle 210 with respect to handle 212, thusfixing a position of a pivot axis for handles 210, 212.

FIGS. 26 and 27 depict partial top views of engagement mechanism 220(with the bias system not shown). As depicted in FIGS. 26 and 27, shaft224 of engagement mechanism 220 may extend from knob 222 through a firstopening in handle 210, through an opening in handle 212, and through asecond opening in handle 210. Handle 210 is able to pivot relative toshaft 224 about pivot axis 238 (depicted in FIG. 27) of the shaft. Endmember 228 may be coupled to shaft 224 to inhibit removal of engagementmechanism 220 from openings in handles 210, 212 during use.

FIG. 26 depicts protrusions 234 on handle 212 and protrusions 236 onmovable member 230 in an unengaged position. With protrusions 234, 236unengaged, shaft 224 and handle 210 may be translated in openings 226,232 (depicted in FIG. 25) towards or away from passage 218 in handle212. Translating shaft 224 may allow a user to adjust a position aboutwhich handle 210 will pivot relative to handle 212. Translating shaft224 may facilitate coupling the adjuster and a closure member drivercoupled to the adjuster to extenders that are secured to a spinalstabilization system.

When a desired relative position of handles 210, 212 has beenestablished, engagement mechanism 220 may be activated (e.g., knob 222may be tightened) to inhibit relative translation of the handles and tofix a position of pivot axis 238 relative to the handles. Tighteningknob 25 222 to engage protrusions 234, 236 may draw movable member 230toward the knob. FIG. 27 depicts engaged protrusions 234, 236. Withpivot axis 238 of handles 210, 212 fixed, handle 210 may rotate relativeto handle 212 when the handles are compressed towards each other.

With pivot axis 238 of handles 210, 212 fixed, a closure member drivercoupled to adjuster by the driver engager may rotate towards an extenderengager of the adjuster when the handles are moved towards each other.The closure member driver may rotate away from the extender engager whenhandles 210, 212 are separated from each other. Pivot axis 238 may beoffset from a shaft of the driver and from the extender engager. Havingpivot axis 238 offset (i.e., not between the shaft of the driver and theextender engager) may allow the adjuster to accommodate variouscurvatures of elongated member that can be positioned in collars of bonefastener assemblies coupled to vertebrae. The ability to accommodate thecurvature of the elongated member may allow the adjuster to move a firstbone fastener assembly towards a second bone fastener assembly. Theability to accommodate the curvature of the elongated member may allow auser to secure a closure member coupled to the first bone fastenerassembly to the elongated member and first bone fastener assembly suchthat the collar of the first bone fastener assembly adjusts to theproper position when the closure member is tightened. In adjusterembodiments that are to be used only with elongated members of apredetermined curvature, the pivot axis of the handles may be locatedbetween the shaft of the driver and the extender engager. The pivot axismay be positioned to accommodate the known curvature of the elongatedmember.

FIG. 28 depicts an embodiment of adjuster 186 that may be used as adistractor. Adjuster 186 may include a bias system. In some embodiments,the bias system includes tension members 214 coupled to handles 210,212. Handle 210 may align with handle 212 so that forces applied to thehandles are directly opposed, thus eliminating or substantiallyeliminating torsional forces during use. Handle 210 may be coupled to anextender engager. In some embodiments, the extender engager may be shaft216. In some embodiments, the extender engager may be a hollow shaftthat fits over an extender. Shaft 216 may be positioned in a firstextender that is coupled to a first collar secured to an elongatedmember of a spinal stabilization system. Handle 210 may include recess240 above the extender engager. Recess 240 may accommodate a portion ofa driver shaft to allow adjuster 186 to be coupled to extenders that areclose together.

In some embodiments, adjuster 186 may include an adjustable pivot axis.The pivot axis may be adjusted using engagement mechanism 220. FIG. 25depicts a partial cut-away view of engagement mechanism 220 with handle212. FIG. 26 depicts engagement mechanism in a position that permitstranslation of handle 210 relative to handle 212. FIG. 27 depictsengagement mechanism in a position that inhibits translation of handle210 relative to handle 212. When engagement mechanism is in the positionthat inhibits translation of handle 210 relative to handle 212, handle210 is able to rotate relative to handle 212 about pivot axis 238 toallow for distraction of vertebrae.

Bone fastener assemblies that are coupled to extenders may be positionedin pedicles of vertebrae that are to be stabilized. An elongated membermay be cut to length and contoured as desired. A medical practitionermay use experience and judgment to determine curvature of the elongatedmember for a patient. Determination of a desired curvature for theelongated member may be facilitated using radiological images of thepatient. In some embodiments, a curvature of the elongated member may bechosen such that, when the elongated member is secured to the collars ofthe bone fastener assemblies, extenders coupled to the bone fastenerassemblies cross at a surface of the skin. Crossing of the extenders ata surface of the skin allows the medical practitioner to minimizeincision length and trauma to the patient. The elongated member may bebent or shaped with a tool (e.g., a rod bender) to allow insertion ofthe elongated member through channels of extenders with various spatiallocations and/or various angular orientations.

An elongated member may be used to provide a desired shape to the spineof a patient. Elongated members may have shapes including, but notlimited to, straight, bent, curved, s-shaped, and z-shaped. FIG. 29depicts an embodiment of S-shaped elongated member 104. FIG. 30 depictsan embodiment of angled elongated member 104. FIG. 31 depicts anembodiment of bent elongated member 104. FIG. 32 depicts an embodimentof straight elongated member 104.

In some embodiments, elongated members 104 may have a substantiallycircular longitudinal cross section. In certain embodiments, elongatedmembers 104 may have other cross-sectional shapes including, but notlimited to, regular shapes (oval, rectangular, rhomboidal, square) andirregular shapes. An instrumentation kit for a spinal stabilizationsystem may include straight rods and/or pre-shaped rods. Straight rodsand/or pre-shaped rods may be contoured to accommodate patient anatomyif needed during the surgical procedure.

Prior to insertion of the elongated member, a tissue wedge or targetingneedle may be used to wand between the bone fasteners to ensure a cleantissue plane has been formed between the bone fasteners. An end of theelongated member may be inserted at an angle or substantiallylongitudinally in a passage and/or channel of an extender coupled to abone fastener assembly. Inserting the elongated member down two or moreextenders and through an open path (i.e., the tissue plane) may allow amedical practitioner to avoid surgical difficulties associated withanatomical abnormalities and/or misalignment of system components. Apositioning tool may be used to guide the elongated member down theextenders into slots in the collars.

During some surgical procedures, a first bone fastener assemblypositioned in a vertebra may be moved along an elongated member towardsa second bone fastener positioned in a second vertebra to achievecompression. An adjuster may be used to compress one or more vertebrallevels of a patient's spine. Compression may be performed sequentiallyat different levels of a multi-level stabilization system. An adjustermay be used by itself or in combination with one or more otherinstruments during a spinal stabilization procedure to achievecompression of vertebrae.

Adjuster 186 depicted in FIG. 24 may be used to compress vertebralbodies coupled to a spinal stabilization system. Adjuster 186 may beused with extenders of various shapes and/or sizes (e.g., lengths) tocompress one or more vertebral levels. Before compression is initiated,elongated member 104 may be positioned in collars 112, 112′ coupled toextenders 170, 170′, as depicted in FIG. 33. Elongated member 104 may beseated in collars 112, 112′. Closure member 106 may be positioned incollar 112. Closure member 106 may be secured (e.g., tightened withoutshearing off the tool portion) in collar 112 to fix elongated member 104in collar 112. In some embodiments, the tool portion of the closuremember may be sheared off. Tightening closure member 106 may alignextender 170 substantially perpendicular to elongated member 104. Asecond closure member may be coupled to a closure member driver. Theclosure member driver may be coupled to the driver engager of theadjuster. A shaft of the closure member driver may be significantlylonger than the length of the adjuster.

Knob 222 of adjuster 186 may be rotated so that engagement mechanism 220allows translation of handle 210 relative to handle 212. Engagementmechanism 220 may be in an unengaged position as represented in FIG. 26.

As depicted in FIG. 34, shaft 216 of adjuster 186 may be positioned inextender 170 coupled to collar 112. Having the engagement mechanism inan unengaged position allows adjuster 186 to accommodate the separationdistance between extenders 170, 170′. Extender 170′ may be moved and/orhandles 210, 212 may be squeezed to facilitate insertion of driver 198in extender 170′. FIG. 35 depicts adjuster 186 with shaft 216 positionedin extender 170 and driver 198 positioned in extender 170′. In someembodiments, the driver may be positioned in extender 170′ prior to theinsertion of shaft 216 in extender 170.

Driver 198 may be rotated in a first direction to seat threading of theclosure member in threading of the collar coupled to extender 170′.Driver 198 may be rotated in the first direction until the closuremember contacts elongated member 104. Driver 198 may then be rotated inthe opposite direction 0.5 to 4 turns to loosen the closure member.Loosening the closure member provides space between the closure member,the collar and elongated member 104 that allows the collar to be movedrelative to the elongated member during compression.

When shaft 216 is positioned in extender 170, driver 198 is positionedin extender 170′, and knob 222 is loosened to allow for translation ofhandle 210 relative to handle 212, tension members 214 may force handle210 away from handle 212 so that the driver is positioned against an endsurface of handle 210 (end surface 242 depicted in FIG. 34). Someseparation distance is needed between driver 198 and the end surface toallow handle 210 to rotate relative to handle 212 when knob 222 has beentightened. To establish a separation distance between driver 198 and theend surface, handles 210, 212 may be squeezed so that handle 210translates towards handle 212. When a desired separation between the endsurface and the shaft of the driver is 29 established, knob 222 may betightened so that translation of handle 210 relative to handle 212 isinhibited. FIG. 27 depicts engagement mechanism 220 when knob 222 istightened.

Referring to FIG. 35, when knob 222 is tightened to inhibit translationof handle 210 relative to handle 212, handle 212 is able to rotaterelative to handle 210. With shaft 216 positioned in extender 170 anddriver 198 positioned through adjuster 186 and in extender 170′, handles210, 212 may be squeezed so that handle 212 rotates relative to handle210. Rotation of handle 212 relative to handle 210 may force extender170′ towards extender 170. When extender 170′ is forced towards extender170, collar 112′ of a bone fastener assembly that is coupled to a firstvertebra may be moved towards collar 112 of a bone fastener assemblythat is coupled to a second vertebra, resulting in compression of thevertebrae. During activation of handles 210, 212 to cause compression,shaft 216 is able to move longitudinally in extender 170 and handle 212is able to move longitudinally relative to driver to accommodate heightchange due to change in position of collar 112′ relative to elongatedmember 104 and/or due to height change due to rotation of handle 212relative to handle 210.

When a desired amount of compression is achieved, driver 198 may be usedto secure the closure member to collar 112′ to fix a position of thecollar relative to elongated member 104. Tightening the closure memberagainst elongated member 104 may cause collar 112′ and extender 170′ torotate so that the collar is oriented substantially perpendicular to theelongated member and the elongated member is fully seated in the collar.FIG. 36 depicts spinal stabilization system 100 after compression withadjuster 186.

The closure member in extender 170′ may be released from driver 198.Driver 198 and adjuster 186 may be removed from extenders 170, 170′. Acounter torque wrench and the driver may be used to shear off the toolportions of the closure members if the stabilization system is in thedesired position.

FIG. 37 depicts compression of multi-level spinal stabilization system100 with adjuster 186. Closure members 106 positioned in collars 112 andtightened against elongated member 104 may inhibit movement of thecollars relative to the elongated member. A closure member positioned incollar 112′ may initially be loose to allow movement of the collarrelative to elongated member 104, but the closure member may betightened using driver 198 when adjuster 186 has positioned the collarat a desired location. In an embodiment, collars 112 may be componentsof bone fastener assemblies that are positioned in the L4 and L5vertebrae. Collar 112′ may be positioned in S1.

During some surgical procedures, a first bone fastener assemblypositioned in a vertebra may be moved along an elongated member awayfrom a second bone fastener positioned in a second vertebra to achievedistraction. An adjuster may be used to distract one or more vertebrallevels of a patient's spine. Distraction may be performed sequentiallyat different levels of a multi-level stabilization system. An adjustermay be used by itself or in combination with one or more otherinstruments during a spinal stabilization procedure to achievedistraction of vertebrae.

Adjuster 186 depicted in FIG. 28 may be used to distract vertebralbodies coupled to a spinal stabilization system. Adjuster 186 may beused with extenders of various shapes and/or sizes (e.g., lengths) todistract one or more vertebral levels. Before distraction is initiated,elongated member 104 may be positioned in collars 112, 112′ coupled toextenders 170, 170′, as depicted in FIG. 33. Elongated member 104 may beseated in collars 112, 112′. Closure member 106 may be positioned incollar 112. Closure member 106 may be secured (e.g., tightened withoutshearing off the tool portion) in collar 112 to fix elongated member 104in collar 112. Tightening closure member 106 may align extender 170substantially perpendicular to elongated member 104. A second closuremember may be coupled to a closure member driver. The closure memberdriver may be coupled to the driver engager of the adjuster.

Knob 222 of adjuster 186 may be rotated so that engagement mechanism 220allows translation of handle 210 relative to handle 212. Engagementmechanism 220 may be in an unengaged position as represented in FIG. 26.

As depicted in FIG. 38, shaft 216 of adjuster 186 may be positioned inextender 170 coupled to collar 112. Elongated member 104 is secured tocollar 112 by closure member 106. Having the engagement mechanism in anunengaged position allows adjuster 186 to accommodate the separationdistance between extenders 170, 170′. Extender 170′ may be moved and/orhandles 210, 212 may be squeezed to facilitate insertion of driver 198in extender 170′. FIG. 39 depicts adjuster 186 with shaft 216 positionedin extender 170 and driver 198 positioned through the adjuster inextender 170′. In some embodiments, the driver may be positioned throughadjuster 186 into extender 170′ prior to the insertion of shaft 216 inextender 170.

Driver 198 may be rotated in a first direction to seat threading of theclosure member in threading of the collar coupled to extender 170′.Driver 198 may be rotated in the first direction until the closuremember contacts elongated member 104. Driver 198 may then be rotated inthe opposite direction 0.5 to 4 turns to loosen the closure member.Loosening the closure member provides space between the closure member,the collar and elongated member 104 that allows the collar to be movedrelative to the elongated member during distraction.

When shaft 216 is positioned in extender 170 and driver 198 ispositioned in extender 170′, knob 222 may be tightened. Tightening knob222 may inhibit translation of handle 210 towards or away from handle212. When knob 222 is tightened to inhibit translation of handle 210relative to handle 212, handle 212 is able to rotate relative to handle210. With shaft 216 positioned in extender 170 and driver 198 positionedthrough adjuster 186 and in extender 170′, handles 210, 212 may besqueezed so that handle 212 rotates relative to handle 210. Rotation ofhandle 212 relative to handle 210 may force extender 170′ away fromextender 170. When extender 170′ is forced away from extender 170,collar 112′ of a bone fastener assembly that is coupled to a firstvertebra may be moved away from collar 112 of a bone fastener assemblythat is coupled to a second vertebra, resulting in distraction of thevertebrae. During activation of handles 210, 212 to cause distraction,shaft 216 is able to move longitudinally in extender 170 and handle 212is able to move longitudinally relative to driver to accommodate heightchange due to change in position of collar 112′ relative to elongatedmember 104 and/or due to height change due to rotation of handle 210relative to handle 212.

When a desired amount of distraction is achieved, driver 198 may be usedto secure the closure member to collar 112′ to fix a position of thecollar relative to elongated member 104. Tightening the closure memberagainst elongated member 104 may cause collar 112′ and extender 170′ torotate so that the collar is oriented substantially perpendicular to theelongated member and the elongated member is fully seated in the collar.FIG. 40 depicts spinal stabilization system 100 after distraction withadjuster 186.

The closure member in extender 170′ may be released from driver 198.Driver 198 and adjuster 186 may be removed from extenders 170, 170′. Acounter torque wrench and the driver may be used to shear off the toolportions of the closure members if the stabilization system is in thedesired position.

Further modifications and alternative embodiments of various aspects ofthe invention will be apparent to those skilled in the art in view ofthis description. Accordingly, this description is to be construed asillustrative only and is for the purpose of teaching those skilled inthe art the general manner of carrying out the invention. It is to beunderstood that the forms of the invention shown and described hereinare to be taken as the presently preferred embodiments. Elements andmaterials may be substituted for those illustrated and described herein,parts and processes may be reversed, and certain features of theinvention may be utilized independently, all as would be apparent to oneskilled in the art after having the benefit of this description of theinvention. Changes may be made in the elements described herein withoutdeparting from the spirit and scope of the invention as described in thefollowing claims.

What is claimed:
 1. A system for adjusting a distance between vertebralbodies of a human spine, comprising: a first extender configured todetachably couple to a first bone fastener assembly that is securable toa first vertebral body; a second extender configured to detachablycouple to a second bone fastener assembly that is securable to a secondvertebral body, wherein one of the first and second bone fastenerassemblies secures to a rod so as to inhibit movement relative to therod, and the other of the first and second bone fastener assemblies ismovably coupled to the rod to allow movement along the rod relative tothe secured bone fastener assembly; and an adjuster having: a handlehaving a longitudinal axis; a pivot member coupled to a first end of thehandle, the pivot member including a driver engager; and a shaft coupledto the first end of the handle, the shaft extending substantiallyperpendicular to the handle, the shaft configured to engage one of thefirst and second extenders.
 2. The system of claim 1, wherein the pivotmember includes a pivot element that rotates freely within a holder,wherein the holder is attached to the handle.
 3. The system of claim 1,wherein the shaft is attached to the handle at a fixed angle.
 4. Thesystem of claim 1, wherein the pivot member is offset laterally from theshaft.
 5. The system of claim 1, wherein the pivot member is alignedalong the longitudinal axis with the shaft.
 6. The system of claim 1,wherein the shaft is configured to be received within one of the firstand second extenders.
 7. The system of claim 1, wherein actuation of adriver engaged with the driver engager towards the handle at the pivotmember forces the extender that is coupled to the bone fastener assemblymovably coupled to the rod to move away from the extender that iscoupled to the bone fastener assembly secured to the rod, whereby thebone fastener assembly movably coupled to the rod is forced to move awayfrom the bone fastener assembly secured to the rod, causing distractionof the first and second vertebral bodies.
 8. The system of claim 1,wherein actuation of a driver engaged with the driver engager away fromthe handle at the pivot member forces the extender that is coupled tothe bone fastener assembly movably coupled to the rod to move towardsthe extender that is coupled to the bone fastener assembly secured tothe rod, whereby the bone fastener assembly movably coupled to the rodis forced to move towards the bone fastener assembly secured to the rod,causing compression of the first and second vertebral bodies.
 9. Thesystem of claim 1, wherein the driver engager includes an openingconfigured to receive the driver.
 10. A system for adjusting a distancebetween vertebral bodies of a human spine, comprising: a first extenderconfigured to detachably couple to a first bone fastener assembly thatis securable to a first vertebral body; a second extender configured todetachably couple to a second bone fastener assembly that is securableto a second vertebral body, wherein one of the first and second bonefastener assemblies secures to a rod so as to inhibit movement relativeto the rod, and the other of the first and second bone fastenerassemblies is movably coupled to the rod to allow movement along the rodrelative to the secured bone fastener assembly; and an adjuster having:a handle having a longitudinal axis; a pivot member coupled to a firstend of the handle, the pivot member including a driver engager; and ashaft coupled to the first end of the handle, the shaft extendingsubstantially perpendicular to the handle, the shaft configured toengage one of the first and second extenders; wherein actuation of adriver engaged with the driver engager relative to the handle at thepivot member forces the extender that is coupled to the bone fastenerassembly movably coupled to the rod to move relative to the extenderthat is coupled to the bone fastener assembly secured to the rod,whereby the bone fastener assembly movably coupled to the rod is forcedto move relative to the bone fastener assembly secured to the rod,causing compression or distraction of the first and second vertebralbodies.
 11. The system of claim 10, wherein the driver engager includesan opening configured to receive the driver.
 12. The system of claim 10,wherein the pivot member includes a pivot element that rotates freelywithin a holder, wherein the holder is attached to the handle.
 13. Thesystem of claim 10, wherein the shaft is attached to the handle at afixed angle.
 14. The system of claim 10, wherein the pivot member isoffset laterally from the shaft.
 15. The system of claim 10, wherein thepivot member is aligned along the longitudinal axis with the shaft. 16.The system of claim 10, wherein the shaft is configured to be receivedwithin one of the first and second extenders.
 17. A method of adjustinga distance between vertebral bodies of a human spine, comprising:securing first and second bone fastener assemblies to first and secondvertebra, respectively; coupling first and second extenders to the firstand second bone fastener assemblies, respectively; securing the firstbone fastener assembly to a rod to inhibit movement of the first bonefastener assembly relative to the rod; coupling the rod to the secondbone fastener assembly, wherein the second bone fastener assembly ismovable along the rod; coupling an adjuster to the first extender via ashaft of the adjuster, wherein the shaft is attached to a handle of theadjuster; inserting a driver through a pivot member of the adjuster intothe second extender, wherein the handle is coupled to the pivot memberand the driver is inserted through a pivot point; actuating the driverrelative to the handle at the pivot point to move the second extenderrelative to the first extender, thereby causing the second bone fastenerassembly secured to the second vertebra to move relative to the firstbone fastener assembly secured to the first vertebra, thereby adjustinga distance between the first vertebra and the second vertebra.
 18. Themethod of claim 17, wherein the shaft is attached to the handle at afixed angle.
 19. The method of claim 17, wherein inserting the driverthrough the pivot member includes inserting the driver through anopening in the pivot member wherein the opening is offset laterally fromthe shaft.
 20. The method of claim 17, wherein inserting the driverthrough the pivot member includes inserting the driver through anopening in the pivot member wherein the opening is aligned along alongitudinal axis of the handle.